Extra-cardiac impedance based hemodynamic assessment method and system

• US 7,925,348 B1
• Filed: 01/26/2010
• Issued: 04/12/2011
• Est. Priority Date: 01/26/2010
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Min, Xiaoyi, Bornzin, Gene A.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US12/694,078
• Time in Patent Office: 441 Days
• Field of Search: 607/23
• US Class Current: 607/23
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A medical device is provided that comprises a lead assembly configured to be at least partially located proximate to the heart. The lead assembly includes an extra-cardiac (EC) electrode to be positioned proximate to at least one of a superior vena cava (SVC) and a left ventricle (LV) of a heart. The lead assembly includes a subcutaneous remote-cardiac (RC) electrode configured to be located remote from the heart such that at least a portion of the greater vessels are interposed between the RC electrode and the EC electrode to establish an extra-cardiac impedance (ECI) vector. The processor module measures extra-cardiac impedance along the ECI vector to obtain ECI measurements. The processor module assesses a hemodynamic performance based on the ECI measurements.

Claims

1. A medical device comprising:

a lead assembly configured to be at least partially located proximate to the heart, the lead assembly including an extra-cardiac (EC) electrode to be positioned proximate to at least one of a superior vena cava (SVC) and a left ventricle (LV) of a heart, the lead assembly including a subcutaneous remote-cardiac (RC) electrode configured to be located remote from the heart such that at least a portion of the greater vessels are interposed between the RC electrode and the EC electrode to establish an extra-cardiac impedance (ECI) vector, and

a processor module to measure extra-cardiac impedance along the ECI vector to obtain ECI measurements, the processor module assessing a hemodynamic performance assessment based on the ECI measurements.

2. The device of claim 1, wherein further comprising memory to store the EC measurements and associated cardiac pacing conditions including at least one of AV delay, V-V delay, stimulation rate, stimulating electrodes chosen for actuating pacing, and stimulation lead configuration.

3. The device of claim 1, wherein the processor module compares the EC measurements to determine a preferred hemodynamic performance based on the EC measurements, the processor module applies a therapy using cardiac pacing conditions associated with the preferred hemodynamic performance based on the stored EC measurements.

4. The device of claim 1, wherein the EC electrode is located outside of the heart and in the SVC and wherein the RC electrode is located in a left subclavical pocket of the patient.

5. The device of claim 1, wherein the lead assembly forms a bipolar impedance configuration that measures impedance between the EC and RC electrodes.

6. The device of claim 1, wherein the ECI vector passes through at least a portion of at least one of pulmonary arteries, pulmonary veins, brachiocephalic arteries and brachiocephalic veins, left carotid artery and left subclavian artery.

7. The device of claim 1, wherein the greater vessels comprise pulmonary arteries, pulmonary veins, brachiocephalic arteries and brachiocephalic veins, left carotid artery and left subclavian artery.

8. The device of claim 1, the processor module to analyze parameters of the ECI measurements for current ECI values relative to ECI thresholds to determine whether sufficient hemodynamic performance exists, wherein hemodynamic performance is comprised of at least one of cardiac output, systolic blood pressure, diastolic blood pressure, contractility, stroke volume, systolic time, and Q-wave to onset of systole, QRS to onset of systole.

9. The device of claim 1, the processor module to obtain baseline ECI values from a baseline ECI measurement when normal hemodynamic performance is present, the processor module utilizing the baseline ECI values to analyze new ECI measurements to determine whether sufficient hemodynamic performance exists.

10. The device of claim 1, further comprising memory to store ECI pattern templates, the processor module to correlate the ECI pattern templates to new ECI measurements to determine whether sufficient hemodynamic performance exists.

11. The device of claim 1, the processor module to determine whether to apply a corrective therapy based on the ECI measurements.

12. The device of claim 1, further comprising cardiac electrodes to collect IEGM signals, the processor module to analyze the IEGM signals utilizing an arrhythmia detection algorithm, the processor module declaring an IEGM based therapy when an arrhythmia episode is identified based on the IEGM signals, the processor module suspending the IEGM based therapy when the ECI measurements indicate that sufficient hemodynamic performance exists.

13. The device of claim 1, further comprising cardiac electrodes to collect IEGM signals, the processor module to analyze the IEGM signals utilizing an arrhythmia detection algorithm, the processor module declares a non-therapy judgment when a rhythm episode is identified based on the IEGM signals, the processor module over-ruling the non-therapy judgment and declaring an ECI based therapy when the ECI measurements indicate that insufficient hemodynamic performance exists.

14. A method for assessing hemodynamic stability, comprising:

providing a lead assembly configured to be at least partially located proximate to the heart, the lead assembly including an extra-cardiac (EC) electrode to be positioned proximate to at least one of a superior vena cava (SVC) and a left ventricle (LV) of a heart, the lead assembly including a subcutaneous remote-cardiac (RC) electrode configured to be located remote from the heart such that at least a portion of the greater vessels are interposed between the RC electrode and the EC electrode to establish an extra-cardiac impedance (ECI) vector;

measuring extra-cardiac impedance along the ECI vector to obtain ECI measurements;

assessing hemodynamic performance based on the ECI measurements.

15. The method of claim 14, further comprising locating the EC electrode is outside of the heart and in the SVC and locating the RC electrode in a left subclavical pocket of the patient.

16. The method of claim 14, further comprising forming a bipolar impedance configuration that measures impedance between the EC and RC electrodes.

17. The method of claim 14, further comprising configuring the ECI vector to pass through at least a portion of at least one of pulmonary arteries, pulmonary veins, brachiocephalic arteries and brachiocephalic veins, left carotid artery and left subclavian artery.

18. The method of claim 14, further comprising analyzing parameters of the ECI measurements for current ECI values relative to ECI thresholds to determine whether sufficient cardiac output exists.

19. The method of claim 14, further comprising obtaining baseline ECI values from a baseline ECI measurement when normal hemodynamic performance is present;

and utilizing the baseline ECI values to analyze new ECI measurements to determine whether sufficient hemodynamic performance exists.

20. The method of claim 14, further comprising determining whether to apply a corrective therapy based on the ECI measurements.